Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study

Cem Gabay; Myriam Riek; Merete Lund Hetland; Ellen-Margrethe Hauge; Karel Pavelka; Matija Tomšič; Helena Canhao; Katerina Chatzidionysiou; Galina Lukina; Dan C Nordström; Elisabeth Lie; Ioan Ancuta; M Victoria Hernández; Piet L M C van Riel; Ronald van Vollenhoven; Tore K Kvien

doi:10.1136/annrheumdis-2015-207760

Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study

Cem Gabay, Myriam Riek, Merete Lund Hetland, Ellen-Margrethe Hauge, Karel Pavelka, Matija Tomšič, Helena Canhao, Katerina Chatzidionysiou, Galina Lukina, Dan C Nordström, Elisabeth Lie, Ioan Ancuta, M Victoria Hernández, Piet L M C van Riel, Ronald van Vollenhoven, Tore K Kvien

Department of Clinical Medicine

47 Citations (Scopus)

Abstract

OBJECTIVES: To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study.

METHODS: Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model.

RESULTS: Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002).

CONCLUSIONS: TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.

Original language	English
Journal	Annals of the Rheumatic Diseases
Volume	75
Issue number	7
Pages (from-to)	1336-42
Number of pages	7
ISSN	0003-4967
DOIs	https://doi.org/10.1136/annrheumdis-2015-207760
Publication status	Published - Jul 2016

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Journal Article

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Gabay, C., Riek, M., Hetland, M. L., Hauge, E-M., Pavelka, K., Tomšič, M., Canhao, H., Chatzidionysiou, K., Lukina, G., Nordström, D. C., Lie, E., Ancuta, I., Hernández, M. V., van Riel, P. L. M. C., van Vollenhoven, R., & Kvien, T. K. (2016). Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study. Annals of the Rheumatic Diseases, 75(7), 1336-42. https://doi.org/10.1136/annrheumdis-2015-207760

Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis : results from a European collaborative study. / Gabay, Cem; Riek, Myriam; Hetland, Merete Lund et al.

In: Annals of the Rheumatic Diseases, Vol. 75, No. 7, 07.2016, p. 1336-42.

Research output: Contribution to journal › Journal article › Research › peer-review

Gabay, C, Riek, M, Hetland, ML, Hauge, E-M, Pavelka, K, Tomšič, M, Canhao, H, Chatzidionysiou, K, Lukina, G, Nordström, DC, Lie, E, Ancuta, I, Hernández, MV, van Riel, PLMC, van Vollenhoven, R & Kvien, TK 2016, 'Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study', Annals of the Rheumatic Diseases, vol. 75, no. 7, pp. 1336-42. https://doi.org/10.1136/annrheumdis-2015-207760

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title = "Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study",

abstract = "OBJECTIVES: To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study.METHODS: Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model.RESULTS: Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002).CONCLUSIONS: TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.",

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author = "Cem Gabay and Myriam Riek and Hetland, {Merete Lund} and Ellen-Margrethe Hauge and Karel Pavelka and Matija Tom{\v s}i{\v c} and Helena Canhao and Katerina Chatzidionysiou and Galina Lukina and Nordstr{\"o}m, {Dan C} and Elisabeth Lie and Ioan Ancuta and Hern{\'a}ndez, {M Victoria} and {van Riel}, {Piet L M C} and {van Vollenhoven}, Ronald and Kvien, {Tore K}",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",

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T1 - Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis

T2 - results from a European collaborative study

AU - Gabay, Cem

AU - Riek, Myriam

AU - Hetland, Merete Lund

AU - Hauge, Ellen-Margrethe

AU - Pavelka, Karel

AU - Tomšič, Matija

AU - Canhao, Helena

AU - Chatzidionysiou, Katerina

AU - Lukina, Galina

AU - Nordström, Dan C

AU - Lie, Elisabeth

AU - Ancuta, Ioan

AU - Hernández, M Victoria

AU - van Riel, Piet L M C

AU - van Vollenhoven, Ronald

AU - Kvien, Tore K

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/7

Y1 - 2016/7

N2 - OBJECTIVES: To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study.METHODS: Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model.RESULTS: Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002).CONCLUSIONS: TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.

AB - OBJECTIVES: To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study.METHODS: Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model.RESULTS: Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002).CONCLUSIONS: TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.

KW - Journal Article

U2 - 10.1136/annrheumdis-2015-207760

DO - 10.1136/annrheumdis-2015-207760

M3 - Journal article

C2 - 26374404

SN - 0003-4967

VL - 75

SP - 1336

EP - 1342

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

IS - 7

ER -

Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study

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